Urethral occluding devices are well known and widely used to prevent urinary incontinence. In particular, a variety of external penile clamps and implanted devices have been proposed for solving urinary leakage problems. Typically, such devices have been employed for use in the inspection and treatment of diseases, wounds and other abnormal conditions of the bodies of humans and lower animals.
The Artificial Urinary Sphincter (AUS 800) is produced by American Medical Systems. The AUS 800 is a totally implantable hydraulic sphincter implanted in both males and females experiencing urinary incontinence. A silicone pressure regulating balloon, silicone control pump, and silicone urethral occlusive cuff are packaged separately for implant. In males for example, an incision is made in the perineum, and a bulbous urethral dissection is performed. The cuff is filled with saline or contrast media and placed around the urethra. The control pump also is filled with saline or contrast media, and placed within the scrotum through this same incision. The pressure regulating balloon is placed into the prevesical space through an additional incision made in the abdomen. Tubing, emanating from each component is routed between incisions and appropriate connections are made. The device is deactivated for a period of approximately six weeks to allow tissue healing to proceed and urethral edema to subside.
At activation, the control pump is squeezed sharply to unseat a puppet and open operational fluid flow paths. The AUS 800 provides a urethral occlusive state. The patient is taught to operate the device by squeezing the control pump through the scrotal skin. This action transfers fluid from the cuff to the pressure regulating balloon. The balloon forces the fluid through a fluid restrictor and back into the cuff to reestablish an occlusive urethral pressure within three to five minutes.
The AUS 800 is a complicated device to implant. The requirement of multiple components and the required intraoperative techniques make it prone to component failure. Some common failures include infection, urethral erosion and atrophy leading to increased urine leakage. Additionally, fluid leaks due to tubing disconnection, intraoperative punctures, and silicone wear within the silicone urethral cuff folds are also causes of device failure.
Urethral and bladder neck slings have long been used in the treatment of female incontinence, but are infrequently used for male urinary incontinence. In the male for example, a perineal or abdominal incision is made and titanium bone screws are place in the pelvic bone. A synthetic or biologic sling material is attached to the screws, which elevate the urethra or bladder neck, thereby applying a compressive force to stop urine leakage.
Studies of autologous tissue slings mention infection and urinary retention requiring intermittent self catheterization, as complications in some patients.
Furthermore, others have employed external penile clamps. The Cunningham clamp, for example, provides a padded, hinged clamp with a latch used to compress the penis. For the clamp to be effective, however, imparts large clamping forces on the penis that often lead to pain, swelling and penile skin break down.
The C3 clamp disclosed in U.S. Pat. No. 5,184,629 provides a clamp intended for use that is limited to approximately one week. The C3 is constructed from a co-extruded and thermoformed polyolefin sheet. The resultant component has two clam shelled halves connected by a hinge. The penis is placed through a portal between the two halves and the halves are folded over to compress the penis. The clam shells are held closed by a Velcro® strap. Force is localized on the urethra by presence of a raised bump on the bottom clam shell half. However, the C3 is available in only two fixed sizes. As there is great penile anatomical variation requiring multiple clamp sizes, it may be frequent that an improper clamp is selected. Further, the ability to operate the strapping system is often difficult for older, arthritic men. Such inconsistencies in sizing and the user dependent strapping system, however, make the C3 less reliable in its ability to control leakage.
Still, others have employed male external (condom) catheters (MEC). These catheters are rolled onto the penis, like a typical condom, and have a specially designed funnel end that connects to a collection device, usually a leg drainage bag. These devices are available in a variety of adhesive application methods due to differences in patient skin sensitivity, changes in penis size during wearing time, penile retraction and manual dexterity. The MEC is typically replaced every twenty-four hours. Difficulties with the MEC include skin sensitivity to materials, tissue sloughing due to the constantly wet environment, manual dexterity required for application, leakage due to adhesive release, and change in penis size during wearing time and penile retraction.
Urethral bulking agents have been injected into the area around the urethra to augment or bulk the sphincter enabling it to coapt and close.
Bulking agents are either synthetic or biologically derived. Biologically derived bulking agents include injections of a patient's own fat cells, polysaccharides or bovine collagen. The body tends to resorb these substances over time, and reinjection over time must be performed. Some synthetic bulking agents, may not be resorbed, but are prone to migrate and reduce coaptation of the urethra. Some of these products may consist of a balloon, which can be reinflated periodically to accommodate changes in continence status, thereby obviating the problems of resorption and migration. Urethral bulking agents have been used extensively in women. However, the performance of injectables in men has not met expectations, and is not widely used. Only 2% to 21% total continence and 19% to 35% improved continence was reported in studies of collagen injections in men.
While these previous applications have provided some advancement for controlling urinary dysfunction and protecting against bladder malfunction, improvements may yet be made to a urethral occlusive assembly for females and males experiencing stress urinary incontinence. There is need for a urethral occlusive assembly that provides optimum comfort and that is convenient for use, while sufficiently preventing urinary leakage. Improvements may still be made to a urethral occlusive assembly that prevents tissue necrosis.